This invention relates to an expandable urinary incontinence device and a method of making the device. More specifically, this invention relates to a non-absorbent urinary incontinence device which is designed to be placed in a woman""s vagina for providing support to a woman""s urethra to prevent the involuntary urine loss commonly associated with stress urinary incontinence.
Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough can increase the intra-abdominal pressure impinging on a person""s bladder and cause the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration. However, when this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, the sphincter muscle can not close properly, therefore, the tendency for involuntary urine loss increases.
As the world""s female population ages, there is an ever increasing need for a non-surgical procedure to reduce the involuntary urine loss commonly associated with xe2x80x9cstress urinary incontinence.xe2x80x9d Today, there are a number of products available for this purpose. Essentially all of these products can only be purchased with a prescription and they need to be physically inserted and/or adjusted by a medical doctor or a nurse practitioner in order to perform correctly.
In view of the general lack of commercially available, non-prescription urinary incontinence devices, it is recognized that there is a need for a urinary incontinence device which can be purchased without a prescription. There is also a need for a urinary incontinence device which is uncomplicated and therefor more user friendly and can be managed by the consumer without the intervention of a medical practitioner. Furthermore, there is a need for a urinary incontinence device which is easy for women to insert into and remove from their bodies, more comfortable to wear and provide psychological and realistic assurance that it is capable of properly performing over an extended period of time.
According to one aspect of the invention, a urinary incontinence device includes a resilient member and a non-absorbent. The non-absorbent and the resilient member are formed into a layered elongated member having a non-absorbent layer and a resilient member layer, wherein a first surface of the resilient member is adjacent and substantially coextensive with a surface of the non-absorbent. The layered elongated member has a first end, a second end, a first portion located adjacent to the first end, a second portion located adjacent to the second end, and a third portion located between the first and second portions. The elongated member is folded upon itself such that the first and second ends are aligned substantially adjacent to one another.
In another aspect of the invention, a urinary incontinence device includes a non-absorbent resilient member formed into an elongated member. The elongated member has a first end, a second end, a first portion located adjacent to said first end, a second portion located adjacent to said second end, and a third portion located between said first and second portions. The elongated member is folded upon itself such that said first and second ends are aligned substantially adjacent to one another.
In yet another aspect of the invention, a method of making a urinary incontinence device is provided. The method includes cutting a resilient member into a desired configuration and then aligning the resilient member upon a non-absorbent such that the resilient member and the non-absorbent are substantially coextensive to form an elongated member having first and second ends. The elongated member is folded upon itself such that said first and second ends are aligned adjacent to one another. The folded elongated member is then compressed into an elongated pledget having an insertion end and a trailing end with the resilient member located at least in the insertion end, whereby the resilient member is capable of expanding at least a portion of the pledget to provide a supportive backdrop for a women""s urethra when the pledget is inserted into a vagina.
Other aspects of the invention will become apparent in view of the appended claims.